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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1308A-004 | Other Identifier | MSD | |
| jRCT2061210033 | Other Identifier | jRCT (Japan Registry of Clinical Trials) | |
| 2023-505698-34-00 | Registry Identifier | EU CT | |
| U1111-1292-3158 | Registry Identifier | UTN | |
| 2020-004490-52 | EudraCT Number |
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The purpose of this study is to evaluate the safety and efficacy of fixed dose coformulated pembrolizumab/quavonlimab (MK-1308A) plus lenvatinib in a first line (1L) hepatocellular carcinoma (HCC) setting. No hypothesis testing will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab/Quavonlimab + Lenvatinib | Experimental | Participants receive pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years, plus lenvatinib orally (based on actual body weight at screening) until progressive disease or unacceptable toxicity for up to 5 years. In the event of discontinuation of pembrolizumab/quavonlimab due to intolerable toxicity, re-initiation of treatment with pembrolizumab may be considered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab/Quavonlimab | Biological | Pembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase | DLTs were defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting >7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting >3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for >1 week (or bilirubin if persists >4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) >10.0 times upper limit of normal (ULN) or >10.0 times baseline if baseline >ULN; any febrile neutropenia Grade 3 or Grade 4; a treatment-related adverse event (AE) causing discontinuation of study intervention during the DLT window; any Grade 5 toxicity. | 3 weeks |
| Number of Participants With ≥1 Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with an AE was reported. | Up to approximately 44 months |
| Number of Participants With ≥1 Serious Adverse Event (SAE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported. | Up to approximately 44 months |
| Number of Participants With ≥1 Immune-related AE (irAE) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center ( Site 0002) | Duarte | California | 91010 | United States | ||
| Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 0013) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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116 participants were enrolled. Of the 116 enrolled participants, 6 participants completed a safety lead-in phase. 1 participant was enrolled in the study in error and did not receive study treatment. After discontinuation of pembrolizumab/quavonlimab, 5 participants switched over to treatment with pembrolizumab plus lenvatinib.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab/Quavonlimab + Lenvatinib | Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2024 |
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| Lenvatinib | Drug | Lenvatinib 12 mg (body weight [BW] ≥60 kg) or 8 mg (BW <60 kg) administered orally every day (QD). |
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| Pembrolizumab | Biological | Pembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab. |
|
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An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs associated with pembrolizumab/quavonlimab exposure may represent an immune-related response. A list of irAEs was pre-specified for the compound of pembrolizumab/quavonlimab. The number of participants with an irAE was reported. |
| Up to approximately 44 months |
| Number of Participants With ≥1 Hepatic AE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event is considered not due to disease progression as judged by the investigator: among participants with Baseline ALT <2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT >3 × the Baseline level; ALT >500 U/L regardless of baseline level; total bilirubin >3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for >3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE was reported. | Up to approximately 44 months |
| Number of Participants Discontinuing Study Treatment Due to an AE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported. | Up to approximately 40 months |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented. | Up to approximately 51 months |
| Up to approximately 51 months |
| Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR | DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented. | Up to approximately 51 months |
| Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | PFS was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported. | Up to approximately 51 months |
| Time-To-Progression (TTP) Per RECIST 1.1 as Assessed by BICR | TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented. | Up to approximately 51 months |
| Overall Survival (OS) | OS was defined as the time from the first dose of study intervention to death due to any cause. | Up to approximately 51 months |
| ORR Per Modified RECIST (mRECIST) as Assessed by BICR | ORR was defined as the percentage of participants who achieve a confirmed CR (disappearance of any intratumoral arterial enhancement in all target lesions) or a PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented. | Up to approximately 51 months |
| DOR Per mRECIST as Assessed by BICR | For participants who demonstrate confirmed CR or PR per mRECIST assessed by BICR, DOR is defined as the time from the first documented evidence of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) until PD or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented. | Up to approximately 51 months |
| DCR Per mRECIST as Assessed by BICR | DCR was defined as the percentage of participants who have achieved CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions), or SD (any cases that do not qualify for either PR or PD) after ≥6 weeks (the start of the window for the first scheduled scan) per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented. | Up to approximately 51 months |
| PFS Per mRECIST as Assessed by BICR | PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported. | Up to approximately 51 months |
| TTP Per mRECIST as Assessed by BICR | TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. TTP per mRECIST as assessed by BICR was presented. | Up to approximately 51 months |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Icahn School of Medicine at Mount Sinai ( Site 0009) | New York | New York | 10029 | United States |
| Oregon Health and Science University ( Site 0006) | Portland | Oregon | 97239 | United States |
| Charleston Oncology ( Site 0003) | Charleston | South Carolina | 29414 | United States |
| Blue Ridge Cancer Care ( Site 0008) | Roanoke | Virginia | 24014 | United States |
| Virginia Mason Medical Center ( Site 0004) | Seattle | Washington | 98101 | United States |
| Anhui Provincial Hospital ( Site 0113) | Hefei | Anhui | 230071 | China |
| Beijing Cancer hospital-Department of Hepato-Pancreato-Biliary Surgery II ( Site 0107) | Beijing | Beijing Municipality | 100142 | China |
| Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 0105) | Fuzhou | Fujian | China |
| Southern Medical University Nanfang Hospital-Liver Cancer Department ( Site 0106) | Guangzhou | Guangdong | 510515 | China |
| Wuhan Union Hospital Cancer Center ( Site 0108) | Wuhan | Hubei | 430022 | China |
| Hunan Cancer Hospital-intervention department ( Site 0109) | Changsha | Hunan | 410013 | China |
| The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit | Xi'an | Shaanxi | 710061 | China |
| Zhongshan Hospital,Fudan University ( Site 0103) | Shanghai | Shanghai Municipality | 200032 | China |
| Huashan Hospital Affiliated Fudan University-Surgery Department ( Site 0118) | Shanghai | Shanghai Municipality | 200040 | China |
| Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0231) | Rozzano | Milano | 20089 | Italy |
| Ospedale San Raffaele-Oncologia Medica ( Site 0227) | Milan | 20132 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0230) | Naples | 80131 | Italy |
| National Cancer Center Hospital East ( Site 0153) | Kashiwa | Chiba | 2778577 | Japan |
| Toranomon Hospital Kajigaya ( Site 0154) | Kawasaki | Kanagawa | 213-8587 | Japan |
| Kindai University Hospital- Osakasayama Campus-Department of Gastroenterology and Hepatology ( Site | Sayama | Osaka | 589-8511 | Japan |
| Hiroshima University Hospital ( Site 0156) | Hiroshima | 734-8551 | Japan |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site | Warsaw | Masovian Voivodeship | 02-034 | Poland |
| Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu ( Site 0249) | Przemyśl | Podkarpackie Voivodeship | 37-700 | Poland |
| Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0247) | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0246) | Koszalin | West Pomeranian Voivodeship | 75-581 | Poland |
| Seoul National University Bundang Hospital-Medical Oncology ( Site 0290) | Seongnam | Kyonggi-do | 13620 | South Korea |
| Samsung Medical Center ( Site 0288) | Seoul | Kyonggi-do | 06351 | South Korea |
| Asan Medical Center ( Site 0289) | Seoul | 05505 | South Korea |
| Hospital Universitario Central de Asturias-Hepatology ( Site 0309) | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 0310) | Barcelona | 08035 | Spain |
| Hôpitaux Universitaires de Genève (HUG) ( Site 0335) | Geneva | Canton of Geneva | 1211 | Switzerland |
| Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 0334) | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| CHUV (centre hospitalier universitaire vaudois) ( Site 0333) | Lausanne | Canton of Vaud | 1011 | Switzerland |
| UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 0332) | Zurich | Canton of Zurich | 8091 | Switzerland |
| Inselspital Bern-Universitätsklinik für Viszerale Chirurgie und Medizin ( Site 0331) | Bern | 3010 | Switzerland |
| NATIONAL CHENG-KUNG UNI. HOSP.-Clinical Trial Research Team of Liver Diseases ( Site 0354) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital-Oncology ( Site 0351) | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( | Taipei | 112201 | Taiwan |
| Treated With Pembrolizumab/Quavonlimab + Lenvatinib |
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| Switched Over to Pembrolizumab + Lenvatinib |
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| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population consisted of all allocated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab/Quavonlimab + Lenvatinib | Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase | DLTs were defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting >7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting >3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for >1 week (or bilirubin if persists >4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) >10.0 times upper limit of normal (ULN) or >10.0 times baseline if baseline >ULN; any febrile neutropenia Grade 3 or Grade 4; a treatment-related adverse event (AE) causing discontinuation of study intervention during the DLT window; any Grade 5 toxicity. | The analysis population consisted of all participants from the safety lead-in phase who received at least one dose of study intervention and who met the criteria for DLT evaluability (ie, finished the DLT-evaluation period without a DLT or experienced a DLT in the DLT-evaluation period). The DLT-evaluation period was 3 weeks. | Posted | Count of Participants | Participants | 3 weeks |
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| Primary | Number of Participants With ≥1 Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with an AE was reported. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 44 months |
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| Primary | Number of Participants With ≥1 Serious Adverse Event (SAE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 44 months |
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| Primary | Number of Participants With ≥1 Immune-related AE (irAE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs associated with pembrolizumab/quavonlimab exposure may represent an immune-related response. A list of irAEs was pre-specified for the compound of pembrolizumab/quavonlimab. The number of participants with an irAE was reported. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 44 months |
|
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| Primary | Number of Participants With ≥1 Hepatic AE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event is considered not due to disease progression as judged by the investigator: among participants with Baseline ALT <2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT >3 × the Baseline level; ALT >500 U/L regardless of baseline level; total bilirubin >3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for >3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE was reported. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 44 months |
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| Primary | Number of Participants Discontinuing Study Treatment Due to an AE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 40 months |
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| Primary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 51 months |
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| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented. | The analysis population consisted of all allocated participants who received at least one dose of study intervention and had a documented confirmed response (complete response [CR] or partial response [PR]) per RECIST 1.1 as assessed by BICR. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
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| Secondary | Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR | DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 51 months |
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| Secondary | Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | PFS was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported. | The analysis population consisted of all allocated participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
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| Secondary | Time-To-Progression (TTP) Per RECIST 1.1 as Assessed by BICR | TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented. | The analysis population consisted of all allocated participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the first dose of study intervention to death due to any cause. | The analysis population consisted of all allocated participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
|
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| Secondary | ORR Per Modified RECIST (mRECIST) as Assessed by BICR | ORR was defined as the percentage of participants who achieve a confirmed CR (disappearance of any intratumoral arterial enhancement in all target lesions) or a PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented. | The analysis population consisted of all allocated participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 51 months |
|
| ||||||||||||||||||||||||||
| Secondary | DOR Per mRECIST as Assessed by BICR | For participants who demonstrate confirmed CR or PR per mRECIST assessed by BICR, DOR is defined as the time from the first documented evidence of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) until PD or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented. | The analysis population consisted of all allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
| |||||||||||||||||||||||||||
| Secondary | DCR Per mRECIST as Assessed by BICR | DCR was defined as the percentage of participants who have achieved CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions), or SD (any cases that do not qualify for either PR or PD) after ≥6 weeks (the start of the window for the first scheduled scan) per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented. | The analysis population consisted of all allocated participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 51 months |
| |||||||||||||||||||||||||||
| Secondary | PFS Per mRECIST as Assessed by BICR | PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported. | The analysis population consisted of all allocated participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
|
| ||||||||||||||||||||||||||
| Secondary | TTP Per mRECIST as Assessed by BICR | TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. TTP per mRECIST as assessed by BICR was presented. | The analysis population consisted of all allocated participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 51 months |
|
|
Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab/Quavonlimab + Lenvatinib | Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. | 86 | 116 | 52 | 115 | 113 | 115 |
| EG001 | Switched Over to MK-3475 + Lenvatinib | At the sponsor's discretion, participants from the pembrolizumab/quavonlimab + lenvatinib arm who discontinued pembrolizumab/quavonlimab switched over to treatment with pembrolizumab via IV infusion Q6W for up to 2 years, plus lenvatinib. | 4 | 5 | 1 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated thyroiditis | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Opsoclonus myoclonus | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sarcoid-like reaction | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Spontaneous haematoma | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Penile blister | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| May 26, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| Participants |
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